|
Post by lakers on Oct 8, 2017 15:04:36 GMT -5
I can see multiple regional partners.
1. UAE, Saudi Arabia, Oman, $100M upfront 2. Canada, $150M 3. Mexico, $150M 4. Australia, $150M 5. Japan with Takeda, $200M 6. India, S Africa with Cipla, $300M 7. China, $500M upfront 8. EU, $300M
Mnkd uses the above funding to market A in the U.S.
Mnkd's mistake with Sny was not allowing or requiring Sny investing $1B for 10% stake, $500M upfront, 30% royalty, no P/L sharing, $1B milestone bonus. This would keep Sny honest regardless of change of regime.
The rumor was Sny's previous CEO wanted to invest in Mnkd. Al turned it down. Wish Al had and watched Shark Tank show where any honest partnership requires a stake.
Needless to say Mnkd should have raised $1B in secondary offering when Pps is > $50.
I guess There is a remote chance Mnkd could partner in U.S. with a top 10 BP in the world with a deal structured similar to the one above.
Mnkd could use the cash to fund TS pipeline.
Negotiate from a position of strength!
|
|
|
Post by lakers on Oct 6, 2017 19:50:25 GMT -5
My hospital has a rule in place that no stock can be purchased in our 401k unless it is $5.00 ps. If I put in an order and it got executed at $4.99 they would cancel the order. I am so Happy I bought a lot at $5.05 in my Roth self directed account. Was wondering if any of you had to deal with This? You got a great steal, $1 pre-reverse split. Check your Roth later Dec 2018. I am confident, you will be much happier! Roth means long term.
|
|
|
Post by lakers on Oct 6, 2017 11:49:06 GMT -5
Right on cue. It's not a coordinated pump, folks! Mnkd deserves $1B-$3B today according to Nate! MannKind (MNKD) PT Raised to $7 at Maxim Group October 6, 2017 12:04 PM Maxim likes MannKind, sees 33% upside Oct. 6, 2017 12:31 PM • SA Editor Douglas W. House Citing lower risk in AFREZZA's relaunch due to the recent labeling revision, Maxim Group ups its price target on MannKind (MNKD +6%) to $7 (33% upside) from $4, not unexpected since shares are currently exchanging hands at ~$5.25.Source: Bloomberg Read more: mnkd.proboards.com/thread/8794/maxim-raised-mnkd-7#ixzz4ukP0bDqH
|
|
|
Post by lakers on Oct 6, 2017 10:12:29 GMT -5
The facility financing obligation(s) of $60 million is secured with assets including intellectual property (IP) and the Danbury, Conn., facility. $45 million at 9.75% interest is payable as follows: $10 million Oct. 31 and $15 million in each July 2018 and 2019. $5 million was converted to equity in June. $15 million of tranche B notes at 8.75% interest are due in $5 million installments each in May 2018 and 2019, and December 2019 So what’s next? MannKind will likely raise capital (debt and equity) but with: 1) a fundamental health-care group and the Mann Family as principal paper holders; 2) a state-of-the-art 260,000-plus square-foot manufacturing plant in Danbury; and 3) an inhalable insulin that could be disruptive to the diabetes market. Read more: mnkd.proboards.com/thread/887/analyst-comments-thread?page=43#ixzz4ujxHGTjkSo, $10M is due Deerfield on 10/31/17. Mnkd needs $90 to extend the runway for 9 months. Most likely, "a fundamental health-care group" will invest $100M in Mnkd for 10% stake for a valuation of $1 B. This will support Pps at $10/sh. This dovetails with Nate's Mnkd low-end valuation. The new label helps Mnkd negotiate from a position of strength! IMHO, Pps will find strong support at $10-$12. Remember Pps rebounded to $2.4 pre-split ($12 post-spit) when Sny returned A to Mnkd in Apr 2016. Rock sold around 10K share ~$2.3/sh pre-split for a big profit. He bought ~ 70 cents/sh upon Sny dumping A. Oct. 5 at 8:16 AM NatesNotes @vibes121 can't tell you about covering (don't know!); still believe "fair value" for $MNKD today is somewhere in the $1B-$3B range (never Oct. 5 at 8:16 AM NatesNotes @vibes121 mind looking out a few years to when Afrezza has captured more of the market) 3 3 Oct. 6 at 6:41 AM NatesNotes @jaguarjkd007 send me an email sometime this morning, Jag, and I'll send you the email I sent out last night for subscribers... Read more: mnkd.proboards.com/thread/8565/nate-on-stocktwits?page=3#ixzz4ujybTPPWIf that Health Care group is a major one like UHC, it will certainly cover A as Tier 1 in 2018. Big win for A. I forgot MC mentioned it as Anthem or Optum? Could someone remind me what new health care group signs up with Mnkd in Jan 2018? Most likely that one will invest in Mnkd TBA this Oct. More good news to come in 3 weeks: recap. A couple of international expansion would be great. BoD and MC are brilliant lately!
|
|
|
Post by lakers on Oct 5, 2017 20:53:40 GMT -5
Danbury Times: FDA approves new label language for Afrezza By Chris Bosak Published 3:45 pm, Tuesday, October 3, 2017 www.newstimes.com/business/article/FDA-approves-new-label-language-for-Afrezza-12250087.phpMannKind received FDA approval to update the label on its inhalable insulin product, Afrezza, in a move that will make it easier to market the drug, the company announced this week. The new label will clarify the starting and mealtime dosages, in addition to listing the initial and peak effects of the drug. “It’s a pivotal moment in the history of the company,” CEO Michael Castagna said during a conference call on Monday. He said the labeling allows the company to eliminate confusing language that has bogged down the label information since it launched Afrezza. “The language really restricted our ability to truly articulate the PK-PD (pharmacokinetic/pharmacodynamic) activity of the product,” he said, adding the company has been working on getting the label updated for about two and a half years. MannKind is based in California and has a large manufacturing facility in Danbury. Investors welcomed the news and the stock rose 7.8 percent to $2.34 per share on Monday. In late trading Tuesday, the stock rose more than 20 percent to $2.81 per share. Castagna highlighted other company milestones during the call. On Sept. 29, Afrezza began its first pediatric trial. It will also file soon with Brazil to have the product sold and marketed there, the first of several international markets in which MannKind intends to sell Afrezza. Castagna said the company is looking to hire a chief marketing officer soon. MannKind has made several top-level management moves this year. Castagna, 40, took over as CEO from Matthew Pfeffer in May. Steven Binder was named CFO and Patrick McCauley the chief commercial officer in July. “We will pull our sales force together to make sure we focus them and get good execution happening here in Q4 and get ready for 2018,” he said. In addition, Castagna said the FDA approved a glucose monitoring system that could spur sales to Type 2 diabetes customers. He said current MannKind sales are evenly split between Type 1 and Type 2 diabetes patients, although 95 percent of overall diabetes patients have Type 2. “ Being able to check your blood sugar without pricking your finger six or seven times a day will make it easier for people to figure out how to manage their glucose control,” he said. The updated label information includes new clinical data that was presented at the American Diabetes Association’s 76th Scientific Sessions in June 2016. “These data articulate the rapid-acting nature of Afrezza to address post-prandial hyperglycemia, setting it apart from other mealtime options available to help patients maintain greater control over their blood glucose levels,” Satish Garg of the Barbara Davis Center for Diabetes at the University of Colorado, said in a statement. cbosak@hearstmediact.com; 203-731-3338
|
|
|
Post by lakers on Oct 5, 2017 19:56:17 GMT -5
MannKind Victorious in Label Revision www.barrons.com/articles/mannkind-victorious-in-label-revision-1507139382The FDA approved label claims of Afrezza’s speed of delivery, rapid glucose control and rapid exit from the body. By Maxim Group ($2.20, Oct. 2, 2017) MannKind announced that the Food and Drug Administration has approved the label revision Afrezza, including for the first time since its 2014 approval demonstration of the “speed” at which Afrezza delivers insulin and manages blood sugar. Speed is key: The label now includes the differentiated pharmacokinetic/pharmacodynamic (PK/PD) profile for Afrezza demonstrating linear kinetics. Both the 4-unit and 12-unit doses appear in the blood in one minute and reach effective (effects on insulin) levels in 12 minutes. Peak effects are reached at 35 minutes for 4 units and 45 minutes for 12 units with the 4-unit and 12-unit returning to baseline after 90 minutes and 180 minutes, respectively. The rapid action and exit should help patients not only better control mealtime sugar levels but also overnight hyperglycemia or Hypoglycemia. [We rate MannKind at Buy with a $4 price target.] Dosing and learning to titrate: For any insulin product, learning to manage the disease and learning about insulin use is key to effective management. The updated label includes an additional step to mealtime dose adjust with Afrezza as individual patients will have different insulin needs. Another step in the restructuring process too: MannKind also announced a warrant exchange (to be completed Oct 3, 2017), exchanging series A and series B warrants that contained reset provisions and limited the amount of capital the company could raise to $10 million. With the warrants off the table (for 1.3 million common shares), the company will have 22 million available shares and can raise as much as $50 million through its at-the-market (ATM) [stock offerings] as it continues to undergo capital restructuring. Conclusion: The label revision is a victory for MannKind as the relaunch of Afrezza continues to build traction. With label claims highlighting Afrezza’s speed of delivery, rapid glucose control and rapid exit from the body, the 100-plus dedicated reps now have a new tool to engage and educate doctors and patients which should help drive adoption. Debt obligations for MannKind ($167 million) consist of $28 million in convertible notes, $60 million in facility financing and $80 million held by the Mann Group. The convertible notes at 5.75% interest are due in 2018. The facility financing obligation(s) of $60 million is secured with assets including intellectual property (IP) and the Danbury, Conn., facility. $45 million at 9.75% interest is payable as follows: $10 million Oct. 31 and $15 million in each July 2018 and 2019. $5 million was converted to equity in June. $15 million of tranche B notes at 8.75% interest are due in $5 million installments each in May 2018 and 2019, and December 2019. On Sept. 29, MannKind completed a warrant exchange; all series A and series B warrants for 1.3 million shares of stock. The warrants contained reset provisions and limited the amount of capital that could be raised to $10 million. With the warrants exchanged, the company has 22 million shares available on the shelf and can raise up to $50 million through its ATM as it continues to work towards restructuring. So what’s next? MannKind will likely raise capital (debt and equity) but with: 1) a fundamental health-care group and the Mann Family as principal paper holders; 2) a state-of-the-art 260,000-plus square-foot manufacturing plant in Danbury; and 3) an inhalable insulin that could be disruptive to the diabetes market. -- Jason Kolbert -- Jason McCarthy
|
|
|
Post by lakers on Oct 5, 2017 12:58:05 GMT -5
A rising share price will make all else look rosy (beer googles). Still hoping for a buyout, one and done! Bite your tongue! Any deal is possible if the offer is great enough, especially when both sides think they screwed the other. The Art of the Deal! Remember People Soft and Oracle?? I agree with Baba.
|
|
|
Post by lakers on Oct 5, 2017 12:49:38 GMT -5
With Novo's Mktg machine, they would make fast acting popular. The tide that raises all boats including your own dream boat. A just happens to be the fastest speed boat which is not a dream but here and now!
You get way ahead of yourself in Lily's 2019 dream boat, my colleague! First mover advantage if commercialized well can be worth a lot.
Novo already made Fast acting hip and popular. See Lily.
|
|
|
Post by lakers on Oct 5, 2017 12:25:42 GMT -5
Big Pharmas are smart. Once they realize A has a good chance to redefine standard of care, no doubt they will swoop in, from my experience. They won't wait till script hits 5K/wk. Now that Novo popularized Fiasp Fast acting, made it sexy, fashionable, trendy, hip, glamorous, other Pharmas gonna trip over themselves to one up that. The only thing that handily beats Fiasp for bolus whether injectable or non injectable is A.
A is mucho more sexy, fashionable, trendy, hip, glamorous, Hollywood, and effective than Fiasp ever dreams of, which sounds like Fiasco, btw.
Despite all that, A is even more practical and cheaper. Let's not forget Mex, Can, U.S. Are NAFTA buddies. That means no tariff, low shipping cost (we share borders. no wall built yet), no refrigeration if used within 30 days.
Of course, BoD (reversed shark tank) will play hard to get maybe accepting $0.5 B for 5% stake, or $10B valuation ($60 ish Pps).
Thank you, Denmark, for your reversed Marshall plan.
To imitate peppy, BPs would look at each other saying Oh chit, we can't let Fiasp dominate the fast acting bolus market, what we gonna do?? Developing Fiasp's Daddy from scratch would take at least $3B, 12 years to gain good FDA approval with no guarantee for success. You know what BPs would do as any smart biz people.
|
|
|
Post by lakers on Oct 5, 2017 10:54:27 GMT -5
How long will it take to breach the followings from now 10/4/17 : 52-week Hi $4.34, 12/20/2016 5-yr Hi $57.4, 6/30/2014 10-yr Hi $61.5, 9/22/2009 Would this make a good poll? Gave shorts a BIG hint yesterday. Only got replies from longs. Short squeeze in earnest. A Bigger hint tomorrow is if script is still in the 400's and PPS keeps rising. What does that tell you? Wall St normally plows money into a turnaround story 3-6 mos in advance. The old adage holds true: amateur investors average down, pros average up. Watch the fireworks, folks! Yawn, are we there yet $27 (ST target by Nates)? If yes, are we there yet $61.5 ? I have to rely on Peppy, Joey to show us their crystal balls. We can start negotiating from a position of Strength.
|
|
|
Post by lakers on Oct 4, 2017 16:28:09 GMT -5
How long will it take to breach the followings from now 10/4/17 :
52-week Hi $4.34, 12/20/2016 5-yr Hi $57.4, 6/30/2014 10-yr Hi $61.5, 9/22/2009
Would this make a good poll?
|
|
|
Post by lakers on Oct 3, 2017 18:30:25 GMT -5
BoD telegraphed confidence in biz dev by raising ATM to $50M. That would improve leverage in negotiations as well. It's a pretty bullish signal. What international expansion announcements (plurals) do you think will be announced next?
Oman, Saudi Arabia were added next to UAE. Why? One stone kills 3 birds? Mexico, Canada: U.S. Is member of NAFTA, no tariff, lower shipping cost. This would make A cheaper than Sanofi's Alpidra, Novo's Faisp. The urgency is now before Trump renegotiates NAFTA. S Africa was added to India. Why? No frig needed if used within 30 days. Cipla? China. Why? 3-way joint venture between a local Chinese firm, AMPH, Mnkd?
|
|
|
Post by lakers on Oct 2, 2017 19:19:37 GMT -5
|
|
|
Post by lakers on Oct 2, 2017 19:08:47 GMT -5
Rose replied:
Our Regulatory Executive had already followed up with the FDA to clarify what the label update would impact.
The approval letter reflects all supplemental NDA approvals (PAS) – they are the documents through the AFREZZA NDA lifecycle that FDA has approved whether MannKind or Sanofi was listed as sponsor. All current labeling that will be posted on DailyMed and on http://www.afrezza.com<http://www.afrezza.com/> will not show Sanofi.
Further, according to the FDA, those pieces with Sanofi references will still remain in the corrected labeling that the FDA sends us as they would in the postings at Drugs@FDA. Having all the pieces attached to the new letter is just a way to keep all of the labeling that has been approved together.
|
|
|
Post by lakers on Oct 2, 2017 16:29:45 GMT -5
Already sent a note to those in charge. Stay tune.
|
|